The healthcare market landscape is quickly changing, and it is necessary to have an anatomic pathology and histology lab partner who can deliver the services you need. A comprehensive anatomic pathology strategy can be a crucial part of clinical and commercial success of your product.

Support for your anatomic pathology needs

With access to commercial clinical laboratories and a full in-house global Anatomic Pathology (AP) service with a foot print in the Americas, Europe, Asia-Pac and China, and a lab operations team who are adept at assay transfer and validation, we have the ability to support your unique study needs. We create customized solutions for every trial, based on tissue and tumor type, staining requirements, and assay need. Download our anatomic pathology services brochure to learn more about our capabilities. 

Histology services – histology is the study of microscopic structure of tissues. We offer a wide range of histology services, from routine procedures to more highly specialized techniques, including tissue fixation, processing, sectioning, staining, immunohistochemistry, and in situ hybridization. All histological methods and procedures were devised to best preserve the cellular detail of a tissue as close to life as possible and our histotechnologists are highly trained.

For specimens received as fresh biopsies, tissue processing is the first step before any downstream histopathology evaluations.

Tissue embedding and sectioning – After the processing cycle, each cassette of tissue is embedded one at a time. Appropriate care is taken for orienting the samples correctly, and the paraffin block is fully formed. We have both manual and automated microtomes for sectioning a block.

Companion Diagnostic experience – Our scientific experts provide you with an optimal path to co-develop your companion diagnostic with clinical development of the therapeutic, regulatory submission and market launch. Our integrated approach is designed so you optimize time to market and commercial success. Learn more about our companion diagnostic capabilities. 

H&E Staining & FISH and IHC services – Hematoxylin & Eosin (H&E) stain is one of the most commonly used stains and is often paired with other common downstream testing like immunohistochemistry (IHC), in-situ hybridization (FISH) and Molecular testing. An IHC test is used to detect the presence or absence and localization of specific proteins by using antibodies. We offer both manual and automated IHC staining on the latest commercial platforms.

Innovation– Our digital pathology solutions promote faster, more collaborative analysis through the use of innovative, leading edge products and services to enable communication of richer efficacy signals faster and more cost-effectively. Learn more about our digital pathology offering.

Globally harmonized Anatomic Pathology in-house services

We offer a quality management system that delivers high quality, dependable data for your study. All clinical laboratories across our regions ensure a globally harmonized SOP process that minimizes technical variability in your study. Our expert pathologists, histotechnologists, clinical, and laboratory staff are trained in good documentation practices, with each AP lab containing on-site experts with >20 years’ experience.

In each of our labs, we have a goal of at least 98% achievement of turnaround time (TAT) for each study. Our Anatomic Pathology laboratories also participate in an accuracy-driven external quality assurance program (CAP Proficiency Testing) that supports our goal of achieving global harmonization, standardization and high quality results across the globe for every study.

Anatomic Pathology for biomarker development in oncology clinical trials  – We can provide customized, global laboratory anatomic pathology lab solutions specifically suited for the unique combinations of therapeutic indication and targeted mechanism-of-action driving modern oncology drug development.

PD-L1 and predictive tissue biomarkers - In immuno-oncology, one of the most current assays is the determination of PD-L1 status in multiple different tumor types, and most of the current assays that are available are based on IHC. There are also other tissue biomarkers of interest that are influencing combination therapy. By introduction of multiplex IHC, a little amount of tissue can show multiple large numbers of output of markers, and multiple markers can be run in the same tissue sample, in the same assay by the application of multiplex IHC. We are developing multiplex IHC assays that would better define and have a larger output from multiple markers from a small piece of tissue. We support a lot of tissue-based testing where our pathologists clearly identify and earmark the areas of tumor. These samples can be taken for downstream molecular analysis, or for ctDNAs or other sequencing methodologies where our experienced pathologists are able to assure the quality of the sample.

Experience predicting and assessing a patient’s response to checkpoint inhibitors is an integral function to immuno-oncology drug development. Once a tissue sample is received, central tissue pathology testing is performed, and data can be mined for immuno-oncology characterizations, such as PD-L1 proteins or tumor-infiltrating lymphocytes. We then take those characterizations and apply them to drug studies, such as the creation of predictive tissue biomarkers for patient selection. 

Digital Pathology: Artificial Intelligence (AI) driven image analysis - Continuously aiming to enable trial sponsors to make smarter decisions throughout the drug development process, Q² Solutions is focused on digitizing image analysis by leveraging AI-based solutions and automated processes. Helping to extract meaningful data-driven insights, AI-based image analysis provides sponsors with much-needed food for thought to effectively accelerate development and initiate drug discovery.

In a complicated clinical trial landscape with increasing growth in pathology cases, experienced pathologists at Q² Solutions are using AI to enhance and tailor-fit image analysis processes and solutions to meet the individual needs and goals of each sponsor’s trial program.  To optimize its AI-driven approach, the expert team emphasizes the importance of:

• Quality control and quality assurance measures, to ensure consistency and better reproducibility in image analysis results.
• High-resolution images, including three dimensional views, to expand data insights that inform decisions.
• Allowing for remote analysis by pathology experts through comprehensive platform to keep analysis timelines moving efficiently.
• Updating necessary hardware tools, and software tools to analyze multiplex images, spatial arrangement of cells, and content base image retrieval (CBIR) to complement speed and quality provided with AI-solutions for faster and enhanced results.
• Continuously fine-tuning software algorithms to produce better insights, or digital assistance to pathologists to assess morphological features that represent continuum biological processes, such as the Gleason score for prostatic carcinoma and breast cancer grading.
• Allowing faster analysis and higher throughput over time with machine learning capabilities to correlate features related to tumor cell morphology, microenvironment, and invasion to define end points of clinical relevance.
• Expanding breadth of collected data insights per image to leverage for future drug discovery and development needs.

Anatomic Pathology lab partner for your success

Q² Solutions has the breadth and depth of scientific experience and expertise across all major therapeutic areas, which help drug developers effectively gain a competitive advantage – helping ensure your success in clinical trials, regulatory approvals and new product launches.